At a glance
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A Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VIS649 Administered Intravenously in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating VIS649 and Placebo for Immunoglobulin A Nephropathy and 2 related conditions. Completed, enrolled 51 participants across 1 site.
Detailed Summary
This is a phase 1, randomized, placebo-controlled, double-blind, single ascending dose study of IV VIS649 in healthy subjects. VIS649 is a monoclonal immunoglobulin G2 (IgG2) antibody targeting the B-cell growth factor APRILL. The study will enroll up to 45 subjects and will be conducted in up to 5 sequential dosing cohorts at four different dose levels, enrolling 9 subjects per cohort. Subjects will be randomized to VIS649 or placebo in a ratio of 7:2 (7 active, 2 placebo). Safety, pharmacokinetic (PK) and pharmacodynamic (PD) data from the initial cohorts will be assessed.
Study Details
Timeline
Interventions
Single IV dose of study product on Day 1 of study
Singe IV dose of placebo administered via IV on Day 1 of study